NCT03746795

Brief Summary

The main aim of this study is to test spirometry measurements using EIT with a calibration using tidal volume obtained from the simultaneous standard spirometry measurement. Another goal is to compare, based on the calibration, the spirometry parameters obtained from separate measurements using EIT and the standard spirometry using a pneumotachograph. All spirometry measurements will be conducted in accordance with the latest available standards of the American Thoracic Society (ATS) and European Respiratory Society (ERS) from the year 2005, including their emendation from 2017.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 27, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2019

Completed
Last Updated

March 11, 2019

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

November 13, 2018

Last Update Submit

March 8, 2019

Conditions

Healthy

Keywords

electrical impedance tomographyspirometric examinationbioimpedanceFVCFEV1Tiffeneau index

Outcome Measures

Primary Outcomes (3)

  • FVC

    forced vital capacity (L)

    through study completion, an average of 1 year

  • FEV1

    forced expiratory volume exhaled in the first second of a forced expiration (L)

    through study completion, an average of 1 year

  • TI

    ratio of FEV1/FVC called Tiffeneau index (-)

    through study completion, an average of 1 year

Study Arms (3)

Standard spirometry

NO INTERVENTION

Standard spirometry measurement with a pneumotachograph alone.

EIT alone

EXPERIMENTAL

Spirometric examinations realized using the EIT

Device: Spirometric examinations realized using the EIT

Simultaneous standard spirometry and EIT

EXPERIMENTAL

Simultaneous measurement by spirometer and EIT

Device: Simultaneous measurement by spirometer and EIT

Interventions

Spirometric examinations realized using the EITDEVICE

Spirometric examinations will be realized using the EIT alone.

EIT alone
Simultaneous measurement by spirometer and EITDEVICE

Spirometric examinations will be realized using the simultaneous measurement by spirometer and EIT

Simultaneous standard spirometry and EIT

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females \> 18 years old
  • Signed informed consent has been obtained

You may not qualify if:

  • Pregnancy
  • Cardiac pacemakers
  • Electrically active implant
  • Critical illness
  • Intrathoracic metal implants
  • Value of body mass index (BMI)\>50

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Technology Faculty of Biomedical Engineering Czech Technical University in Prague

Kladno, Czech Republic, 272 01, Czechia

Location

Related Publications (4)

  • Ngo C, Leonhardt S, Zhang T, Luken M, Misgeld B, Vollmer T, Tenbrock K, Lehmann S. Linearity of electrical impedance tomography during maximum effort breathing and forced expiration maneuvers. Physiol Meas. 2017 Jan;38(1):77-86. doi: 10.1088/1361-6579/38/1/77. Epub 2016 Dec 22.

    PMID: 28004642BACKGROUND

  • Vogt B, Lohr S, Zhao Z, Falkenberg C, Ankermann T, Weiler N, Frerichs I. Regional lung function testing in children using electrical impedance tomography. Pediatr Pulmonol. 2018 Mar;53(3):293-301. doi: 10.1002/ppul.23912. Epub 2017 Nov 14.

    PMID: 29136345BACKGROUND

  • Lehmann S, Leonhardt S, Ngo C, Bergmann L, Ayed I, Schrading S, Tenbrock K. Global and regional lung function in cystic fibrosis measured by electrical impedance tomography. Pediatr Pulmonol. 2016 Nov;51(11):1191-1199. doi: 10.1002/ppul.23444. Epub 2016 Apr 29.

    PMID: 27127915BACKGROUND

  • Vogt B, Zhao Z, Zabel P, Weiler N, Frerichs I. Regional lung response to bronchodilator reversibility testing determined by electrical impedance tomography in chronic obstructive pulmonary disease. Am J Physiol Lung Cell Mol Physiol. 2016 Jul 1;311(1):L8-L19. doi: 10.1152/ajplung.00463.2015. Epub 2016 May 17.

    PMID: 27190067BACKGROUND

Study Officials

  • Karel Roubík, prof.

    Czech Technical University in Prague, FBMI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: During the experiment, six measurements will be performed for each examined individual to calculate the spirometric parameters of FVC, FEV1 and Tiffenea's index (TI) FEV1/FVC. Spirometry measurements will be performed in a randomized order: two standard spirometric examinations, two spirometric examinations using EIT and two simultaneous measurements using both methods. Each subject will undergo all six measurements.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 20, 2018

Study Start

October 27, 2017

Primary Completion

January 30, 2018

Study Completion

March 8, 2019

Last Updated

March 11, 2019

Record last verified: 2018-11

Locations

CZ(1)